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Saturday, January 19, 2019
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GCP 2: Good Clinical Practice, Level 2 (GCPR2)

Certification Training Duration: 2.8 hours (the average time to complete the training program, including final assessments).
Credits Hours: 3
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.

BioPharma Institute LogoTraining Program: GCP 2: Good Clinical Practice, Level 2
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. Good Clinical Practice (GCP) refers to a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve human subjects. GCP compliance ensures the protection of the rights, safety, and well-being of trial subjects and the credibility and integrity of clinical trial data. This course reviews the standards used in clinical studies from start-up to post-study audits.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, user name, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced training: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


The GCP 2: Good Clinical Practice, Level 2 course is found in the following professional certification program(s):


COURSE OUTLINE:


INTRODUCTION
1. Course Information
2. Interface Tour
3. Course Overview

STUDY START-UP:RESPONSIBILITIES
4. Objectives
5. GCP Guidelines
6. Investigator`s Responsibilities
7. Sponsor`s Responsibilities
8. Recordkeeping for Investigators
9. Recordkeeping for Sponsors and Monitors
10. The Evaluation Visit
11. Progress Check

STUDY START-UP: PROTECTION OF SUBJECTS
12. Objectives
13. Purpose of IRBs
14. Investigator-IRB Relationship
15. IRB Records and Reviews
16. Informed Consent: General Requirements
17. Informed Consent Process
18. The Informed Consent Document
19. Progress Check

DURING THE STUDY
20. Objectives
21. Investigator`s Responsibilities
22. Recordkeeping for Investigators
23. Investigator-IRB Interactions
24. Handling Investigational Product
25. Managing Adverse Events
26. Regulatory Evaluations
27. Progress Check

AFTER THE STUDY
28. Objectives
29. Preparing for an Audit
30. Record-keeping
31. Disqualification
32. Progress Check

COURSE OBJECTIVES:


Explain the role GCP plays in ensuring subjects are protected.
List the investigator and sponsor`s responsibilities prior to study start-up.
Describe the documents found in a study file.
Explain the purpose of the evaluation visit.
List the functions of Independent Review Boards (IRBs or IECs).
Describe the investigator-IRB interaction.
Explain how informed consent is achieved.
List the essential elements of the informed consent document.
List the investigator`s ongoing responsibilities during a clinical trial.
List the documents maintained during a clinical trial.
Describe the interactions between an investigator and IRB once the clinical trial has commenced.
Explain how the investigator maintains accountability of the investigational product.
Describe how adverse events are recorded and reported. Explain what is meant by a `complete` record.
Describe the types of records that must be kept following NDA approval, or the termination of a clinical trial.
Describe the process of disqualification.


For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.

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